FDA Adverse Event Injury Summary report: N

PERINATAL PRODUCTS INFANT CRIB WARMER

MDR report key: 7076 · Received November 12, 1993

Report

Report Number: 7076
Event Type: Injury
Date Received: November 12, 1993
Date of Event: November 7, 1993
Report Date: November 10, 1993
Manufacturer: TRANSIDYNE GENERAL CORP.
Product Code: FMT
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

COMPROMISED NEWBORN PLACED ON INFANT CRIB WARMER WITH BLANKET BETWEEN FOR 20 MINS DURING RESUSCITATION EFFORTS. AFTER INFANT STABILIZED, MOVED TO ISOLETTE WITH OXYHOOD AT O2 100% CRIB WARMER PLACED UNDER CHILD WITH BLANKET BETWEEN. FIFTEEN MINS LATER BLISTERS NOTED ON LEFT ARM, SHOULDERS, NECK AND BACK OF HEAD OF NEONATE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: LABELING - INADEQUATE INSTRUCTIONS FOR USE, TELEMETRY FAILURE, NONE OR UNKNOWN, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PERINATAL PRODUCTS INFANT CRIB WARMER		FMT	TRANSIDYNE GENERAL CORP.	1630	30106

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention