ZIPPIE VOYAGE
Report
- Report Number
- 9616084-2021-00064
- Event Type
- Malfunction
- Date Received
- December 3, 2021
- Date of Event
- November 1, 2020
- Report Date
- December 3, 2021
- Manufacturer
- SUNRISE MEDICAL (US) LLC
- Product Code
- INM
- UDI-DI
- 00016958053647
- Removal / Correction Number
- 88257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
BACKGROUND INFORMATION: PLEASE REFERENCE ZIPPIE VOYAGE RECALL (RES# 88257) REGARDING NEW REMEDIATION FOR THIS ISSUE. THIS MDR IS BEING FILED DUE TO SEVERITY OF POTENTIAL INJURY AND UPDATED RISK FILE FOR THIS FAILURE MODE. WHILE THERE IS NO DESIGN, MANUFACTURING, OR ASSEMBLY MALFUNCTION, THERE IS A KNOWN POTENTIAL MALFUNCTION ON THE PART OF THE CAREGIVER WHEN NOT ADEQUATELY ATTACHING THE DETACHABLE SEAT FROM THE EARLY INTERVENTION STROLLER. FULL DETAILS OF THE VOLUNTARY FIELD SAFETY NOTICE ARE FILED WITHIN SUNRISE MEDICAL RECALL FILE (B)(4). CAREGIVER DID NOT HAVE TETHER INSTALLED. ZIPPIE VOYAGE OWNER MANUAL (245797, REV. B, SECTION VIII: USE & MAINTENANCE, PAGE 15, SECTION I: SEATING INSTALLATION) STATES "USING THE LATCH LOCK: A. BEFORE ATTACHING OR REMOVING THE SEAT TO OR FROM THE BASE, THE LATCH LOCK (K) MUST BE SLID TO THE RIGHT (UNLOCKED POSITION) AS SHOWN IN FIG 14. B. TO PREVENT INADVERTENT ACTIVATION OF THE SEAT LATCH, SLIDE THE LATCH LOCK TO THE LEFT AS SHOWN IN FIG 15 AFTER THE SEAT IS FULLY SECURED TO THE BASE (YOU CANNOT ATTACH SEAT TO BASE WHILE LOCK IS ENGAGED)." AND "B. ENSURE ALL POSITIONING STRAPS AND ACCESSORIES ARE OUT OF THE WAY AND WILL NOT INTERFERE WITH THE SEAT FROM FULLY ENGAGING THE RECEIVER." RISK ANALYSIS (UFMEA EARLY INTERVENTION STROLLERS MASTER, RISK ID 73) LISTS "SEAT SYSTEM DETACHES FROM STROLLER BASE WHEN IN USE" AS A KNOWN FAILURE MODE. UNMITIGATED RISK IS SCORED AS "UNACCEPTABLE." MITIGATED RISK (ADDITION OF SAFETY TETHER) IS SCORED AS "ACCEPTABLE." DISCUSSION: BASED ON THE MOTHER'S DESCRIPTION OF THE INCIDENT, ROOT CAUSE OF THE REPORTED INCIDENT IS MOST LIKELY DUE TO THE CAREGIVER INADEQUATELY ATTACHING THE DETACHABLE STROLLER SEAT, POTENTIALLY DUE TO FOREIGN OBJECT INTERFERENCE. THERE IS NO CONFIRMATION OF LATCH MALFUNCTION OR MALFUNCTION OF THE STROLLER BASE THROUGH DEALER INVESTIGATION OR USER REPORT. THIS DETACHABLE CONFIGURATION IS A USER REQUIREMENT (MARKET REQUIREMENT). THE ISSUE IS MOST LIKELY DUE TO THE LACK OF A FAILSAFE DEVICE SUCH AS THE VOYAGE SAFETY TETHER KIT WHICH IS BEING SENT OUT TO ALL DEVICE OWNERS AS PART OF THE AFOREMENTIONED RECALL. CONCLUSION: WHILE THERE MAY OR MAY NOT BE A MALFUNCTION OF THE DEVICE LEADING TO THE SEAT DETACHMENT, DUE TO THE UNEXPECTED DETACHMENT AND LACK OF A FAILSAFE DEVICE, THIS MDR IS BEING FILED. THE VOYAGE 2021 RECALL ADDRESSES THE REMEDIATION OF THIS DEVICE. NO FURTHER INVESTIGATION WILL BE PERFORMED IN THIS CASE AS THE CAUSE IS ULTIMATELY THE LACK OF A FAILSAFE DEVICE WHICH IS BEING ACTIVELY REMEDIATED.
BACKGROUND INFORMATION: PLEASE REFERENCE ZIPPIE VOYAGE RECALL (RES# 88257) REGARDING NEW REMEDIATION FOR THIS ISSUE. THIS MDR IS BEING FILED DUE TO SEVERITY OF POTENTIAL INJURY AND UPDATED RISK FILE FOR THIS FAILURE MODE. WHILE THERE IS NO DESIGN, MANUFACTURING, OR ASSEMBLY MALFUNCTION, THERE IS A KNOWN POTENTIAL MALFUNCTION ON THE PART OF THE CAREGIVER WHEN NOT ADEQUATELY ATTACHING THE DETACHABLE SEAT FROM THE EARLY INTERVENTION STROLLER. FULL DETAILS OF THE VOLUNTARY FIELD SAFETY NOTICE ARE FILED WITHIN SUNRISE MEDICAL RECALL FILE (B)(4). CAREGIVER DID NOT HAVE TETHER INSTALLED. ZIPPIE VOYAGE OWNER MANUAL (245797, REV. B, SECTION VIII: USE & MAINTENANCE, PAGE 15, SECTION I: SEATING INSTALLATION) STATES "USING THE LATCH LOCK: A. BEFORE ATTACHING OR REMOVING THE SEAT TO OR FROM THE BASE, THE LATCH LOCK (K) MUST BE SLID TO THE RIGHT (UNLOCKED POSITION) AS SHOWN IN FIG 14. B. TO PREVENT INADVERTENT ACTIVATION OF THE SEAT LATCH, SLIDE THE LATCH LOCK TO THE LEFT AS SHOWN IN FIG 15 AFTER THE SEAT IS FULLY SECURED TO THE BASE (YOU CANNOT ATTACH SEAT TO BASE WHILE LOCK IS ENGAGED)." AND "B. ENSURE ALL POSITIONING STRAPS AND ACCESSORIES ARE OUT OF THE WAY AND WILL NOT INTERFERE WITH THE SEAT FROM FULLY ENGAGING THE RECEIVER." RISK ANALYSIS (UFMEA EARLY INTERVENTION STROLLERS MASTER, RISK ID 73) LISTS "SEAT SYSTEM DETACHES FROM STROLLER BASE WHEN IN USE" AS A KNOWN FAILURE MODE. UNMITIGATED RISK IS SCORED AS "UNACCEPTABLE." MITIGATED RISK (ADDITION OF SAFETY TETHER) IS SCORED AS "ACCEPTABLE." DISCUSSION: BASED ON THE MOTHER'S DESCRIPTION OF THE INCIDENT, ROOT CAUSE OF THE REPORTED INCIDENT IS MOST LIKELY DUE TO THE CAREGIVER INADEQUATELY ATTACHING THE DETACHABLE STROLLER SEAT, POTENTIALLY DUE TO FOREIGN OBJECT INTERFERENCE. THERE IS NO CONFIRMATION OF LATCH MALFUNCTION OR MALFUNCTION OF THE STROLLER BASE THROUGH DEALER INVESTIGATION OR USER REPORT. THIS DETACHABLE CONFIGURATION IS A USER REQUIREMENT (MARKET REQUIREMENT). THE ISSUE IS MOST LIKELY DUE TO THE LACK OF A FAILSAFE DEVICE SUCH AS THE VOYAGE SAFETY TETHER KIT WHICH IS BEING SENT OUT TO ALL DEVICE OWNERS AS PART OF THE AFOREMENTIONED RECALL. CONCLUSION: WHILE THERE MAY OR MAY NOT BE A MALFUNCTION OF THE DEVICE LEADING TO THE SEAT DETACHMENT, DUE TO THE UNEXPECTED DETACHMENT AND LACK OF A FAILSAFE DEVICE, THIS MDR IS BEING FILED. THE VOYAGE 2021 RECALL ADDRESSES THE REMEDIATION OF THIS DEVICE. NO FURTHER INVESTIGATION WILL BE PERFORMED IN THIS CASE AS THE CAUSE IS ULTIMATELY THE LACK OF A FAILSAFE DEVICE WHICH IS BEING ACTIVELY REMEDIATED.
THE CAREGIVER/MOTHER DESCRIBES AN INCIDENT THAT OCCURRED "ABOUT A YEAR AGO" WHEN HER SON (DATE UNSPECIFIED) WAS ROCKING BACK AND FORTH WHEN THE SEATING SYSTEM DETACHED FROM THE STROLLER BASE AND FELL TO THE GROUND. NO MEDICAL ATTENTION WAS SOUGHT ALTHOUGH MOTHER REPORTS A "BUSTED FACE." THE MOTHER HAS SINCE STOPPED USING THE STROLLER DUE TO THE REPORT THAT "THE STROLLER BASE IS TOO HEAVY TO LIFT INTO THE CAR." THE MOTHER CALLED IN TO CUSTOMER SERVICE DUE TO RECEIVING THE RECALL NOTIFICATION IN THE MAIL (RECALL NO. 88257).
THE CAREGIVER/MOTHER DESCRIBES AN INCIDENT THAT OCCURRED "ABOUT A YEAR AGO" WHEN HER SON (DATE UNSPECIFIED) WAS ROCKING BACK AND FORTH WHEN THE SEATING SYSTEM DETACHED FROM THE STROLLER BASE AND FELL TO THE GROUND. NO MEDICAL ATTENTION WAS SOUGHT ALTHOUGH MOTHER REPORTS A "BUSTED FACE." THE MOTHER HAS SINCE STOPPED USING THE STROLLER DUE TO THE REPORT THAT "THE STROLLER BASE IS TOO HEAVY TO LIFT INTO THE CAR." THE MOTHER CALLED IN TO CUSTOMER SERVICE DUE TO RECEIVING THE RECALL NOTIFICATION IN THE MAIL (RECALL NO. 88257).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1822208 | ZIPPIE VOYAGE | EARLY INTERVENTION STROLLER | INM | SUNRISE MEDICAL (US) LLC | 16 | 00016958053647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |