MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform for evaluation.The investigation is on-going, when completed a supplemental report will be filed.

Event Description

During shift check, the autopulse platform ((b)(4)) was displaying error message user advisory (ua) 41 (patient temperature sensor failure).No patient involvement was reported.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed in the archive review but not during the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported (ua) 41 error message.No physical damage was observed during visual inspection.The encoder drive shaft does not rotate smoothly, exhibits binding and resistance unrelated to the reported issue.Review of the archive data show (ua) 41 error messages occurred on the reported event date.Functional testing was performed and found no issue.Additionally, as a precautionary measure, the temperature sensor and power distribution board (pdb) were replaced.Clutch plate deburring was performed to remedy the sticky clutch noted during visual inspection.The platform was tested using the manikin with lrtf (large resuscitation test fixture) with a good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 7449397
• MDR Text Key: 106307463
• Report Number: 3010617000-2018-00467
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1